Is IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE FDA approved?

Yes, IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is FDA approved (first approved 2010-11-22) and manufactured by BIONPHARMA.

Who makes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE?

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is manufactured by BIONPHARMA.

Data updated: Mar 10, 2026

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Q: What is IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE used for?

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is an FDA-approved medication. See full prescribing information for approved uses.

DIPHENHYDRAMINE HYDROCHLORIDE

Approved 2010-11-22

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Indications

Phase 3 Trials

Years on Market

Details

Status: Over-the-counter
First Approved: 2010-11-22
Routes: ORAL
Dosage Forms: CAPSULE

Companies

BIONPHARMA ONESOURCE SPECIALTY Aurobindo Pharma

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE , IBUPROFEN

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE Approval History

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What IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE Treats

3 FDA approvals

Originally approved for its first indication in 2010 . Covers 3 distinct patient populations.

Other (3)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA090397 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.